BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPMI VARIO / FLOOR STAND S88

    MDR report key: 3591422 · Received January 9, 2014

    Report

    Report Number
    9615010-2014-00001
    Event Type
    Injury
    Date Received
    January 9, 2014
    Date of Event
    December 11, 2013
    Report Date
    January 9, 2014
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    EPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SAFETY ENGINEER (FSE) INSPECTED THE DEVICE AND FOUND THE LAMP MODULE STUCK IN THE LAMP SUPPLY. THE LAMP #1 CERAMIC SOCKET WAS BROKEN, THE FILAMENT WAS LOOSE AND THERE WERE PIECES OF CERAMIC IN THE MODULE. THE LAMP #2 ELECTRICAL CONNECTOR WAS BURNED AND THE CONTACT PIN WAS MISSING. THE LAMP MODULE WAS THE ORIGINAL (SYSTEM MANUFACTURED IN 2007). THE USER MANUAL IDENTIFIES THE LAMP LIFETIME AS 500 HOURS. THE LAMP MODULE IS INTENDED TO BE REPLACED AS A UNIT WHEN LAMPS FAIL. THE USER MANUAL HAS A "CHECKLIST FOR USE" WHICH INSTRUCTS THE USER TO CHECK THE LIGHT BRIGHTNESS BEFORE EVERY SURGERY. IN THE SITUATION WHERE MICROSCOPE ILLUMINATION IS UNAVAILABLE, THE USER MANUAL ADVISES HAVING AN INDEPENDENT ILLUMINATION SOURCE AVAILABLE: "LIKE ANY TECHNICAL DEVICE USED IN THE OPERATING ROOM, THIS ILLUMINATION MAY FAIL. IT IS THUS RECOMMENDED TO HAVE A SUITABLE BACKUP LAMP, SUCH AS AN OPERATING ROOM ILLUMINATOR READY AT HAND DURING SURGERY." (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LIGHTING PROBLEMS WITH AN OPMI VARIO MICROSCOPE MOUNTED ON AN S88 FLOOR STAND INTENDED FOR USE IN A LAMINECTOMY PROCEDURE. AFTER THE SURGEON HAD MADE THE INCISION AND EXPOSED THE LAMINA OF THE L3 AND L4 VERTEBRAE, THE MICROSCOPE WAS MOVED INTO POSITION. THE SURGEON DETERMINED THE LIGHT FROM LAMP #1 TO BE TOO DIM AND ATTEMPTED TO SWITCH TO LAMP #2. IN THE PROCESS OF SWITCHING TO LAMP #2, THE CERAMIC SOCKET FOR LAMP #1 BROKE, PROBLEMS WERE ENCOUNTERED REINSTALLING THE LAMP MODULE AND THE MICROSCOPE ILLUMINATION WAS LOST. THE SURGEON MADE THE DECISION TO ABORT AND RESCHEDULE THE PROCEDURE AND TRANSFER THE PATIENT TO THE INTENSIVE CARE UNIT. THE RESCHEDULED SURGERY WAS PERFORMED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17826 OPMI VARIO / FLOOR STAND S88 MICROSCOPE, SURGICAL, GENERAL & PLASTIC EPT CARL ZEISS MEDITEC AG OPMI VARIO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization